Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, HER2-negative breast cancer: final overall survival analysis of the phase III TROPION-Breast01 study.

In this article, we report results from the final overall survival(OS) analysis.

在本文中，我们报告了最终总生存(OS)分析的结果。

patients_and_methods

Patients with inoperable/metastatic HR-positive/HER2-negative breast cancer, who had disease progression on endocrine therapy and for whom endocrine therapy was unsuitable, and had received one to two prior lines of chemotherapy in the inoperable/metastatic setting were randomly assigned in a 1 : 1 ratio to Dato-DXd (6 mg/kg every 3 weeks) or ICC (eribulin/capecitabine/vinorelbine/gemcitabine).

无法手术/转移性HR阳性/HER2阴性乳腺癌患者，对内分泌治疗有疾病进展且内分泌治疗不适用，并且在无法手术/转移性设置中接受了一到两线化疗，被随机分配到Dato-DXd（每3周6 mg/kg）或ICC（eribulin/卡培他滨/长春瑞滨/吉西他滨）以1:1的比例。

Dual primary endpoints were PFS by BICR and OS.

双重主要终点是BICR评估的无进展生存期（PFS）和总生存期（OS）。

Results

At data cut-off, median follow-up was 22.8 months.

在数据截止时，中位随访时间为22.8个月。

OS for the Dato-DXd versus ICC arm did not reach statistical significance (hazard ratio1.01, 95% confidence interval0.83-1.22, P = 0.9445).

Dato-DXd与ICC组的总生存期未达到统计学显著性差异（风险比1.01，95%置信区间0.83-1.22，P=0.9445）。

Use of ADCs (trastuzumab deruxtecan and sacituzumab govitecan) as subsequent therapy was imbalanced: 12.3% in the Dato-DXd arm versus 24.0% in the ICC arm.

ADCs（trastuzumab deruxtecan和sacituzumab govitecan）作为后续治疗的使用不平衡：Dato-DXd组为12.3%，而ICC组为24.0%。

Secondary efficacy endpoints (PFS by investigator assessment, objective response rate, duration of response, disease control rate at 12 weeks, time to first and second subsequent therapy or death, and time to second progression or death) continued to favor Dato-DXd at this final analysis.

次要疗效终点（由研究者评估的PFS、客观缓解率、反应持续时间、12周疾病控制率、首次和第二次后续治疗或死亡的时间，以及第二次进展或死亡的时间）在本次最终分析中继续倾向于Dato-DXd。

The overall safety profile of Dato-DXd remained favorable compared with ICC, and no new safety signals were observed with longer follow-up.

Dato-DXd的安全性总体概况与ICC相比保持良好，随着随访时间的延长，并未观察到新的安全信号。

Conclusions

TROPION-Breast01 met its dual primary endpoint of PFS by BICR.

TROPION-Breast01达到了其双重主要终点，即由BICR评估的无进展生存期（PFS）。

While there was no statistically significant improvement in the dual primary endpoint of OS with Dato-DXd versus ICC, subsequent ADC treatment may have affected OS results.

尽管在总生存（OS）这一双重主要终点上，Dato-DXd与ICC相比没有统计学上的显著改善，但随后的抗体药物偶联物（ADC）治疗可能影响了OS结果。

The totality of efficacy and safety data supports Dato-DXd as a new treatment option for patients with previously treated, inoperable/metastatic HR-positive/HER2-negative breast cancer.

综合疗效和安全性数据支持Dato-DXd作为之前接受过治疗、无法手术/转移性、激素受体阳性/人表皮生长因子受体2阴性乳腺癌患者的新型治疗选择。